Managing Innovation, Design and Creativity

Chapter 14. Innovation and industry context

CASE STUDY 5: ROCHE-SAQUINAVIR^[50](A)

1995 – a new class of HIV antiviral

On 6 December 1995 the US Food and Drug Administration (FDA) cleared Roche's new HIV drug, Invirase® (saquinavir) for use in combination with approved nucleoside analogues for selected individuals with advanced HIV disease. This decision to approve Invirase as quickly as possible was addressed in the US media as, "Some of the most hopeful news in years for people living with AIDS. This approval introduces a new class of drugs for treating AIDS." Until 1995, HIV therapy had been limited to the use of combination regimens comprising two drugs that were designed to prevent the virus from infecting the cell. The introduction of Invirase enabled the use of new combination regimens that would target the virus at two steps in the replication cycle – providing a "one-two punch" approach. Like many other infectious agents, immunodeficiency viruses had an unfortunate tendency to mutate in such a way that they would become resistant to individual substances used to attack them. As many as 40% of HIV/AIDS patients had failed multiple treatment regimens or had developed resistance to existing options.

While AIDS-related deaths had declined since the introduction of Invirase and subsequent HIV protease inhibitors, the number of people living with HIV continued to grow. The use of triple combination therapy, pioneered in Roche's Phase III clinical trials became known as HAART (Highly ...